BioCentury | Oct 26, 2018
Politics & Policy

FDA grants first qualification of a clinical safety biomarker

...kidney injury molecule 1 (KIM-1), clusterin (CLU; APOJ), osteopontin (Opn; Spp1), lipocalin 2 (LCN2; NGAL), cystatin...
BioCentury | Dec 31, 2016
Finance

SMA(ll) wonder

...cells/mL. About 33% had elevated urine protein, but none had elevations in serum creatinine or cystatin...
BioCentury | Feb 1, 2016
Clinical News

Pyridoxamine: Phase III ongoing

...ESRD); time to composite endpoint of >=100% serum creatinine increase or ESRD, change in serum cystatin-C...
BioCentury | Dec 21, 2015
Clinical News

Masitinib: Completed Phase III enrollment

...36, number of failures defined as 6-point drop in ALSFRS-R or death, overall survival (OS), cystatin...
BioCentury | Mar 2, 2015
Clinical News

Astragraf XL tacrolimus: Phase IIIb data

...Advagraf plus MMF and Simulect missed the secondary endpoints of increasing eGFR as measured by cystatin...
...Advagraf plus MMF and Simulect missed the secondary endpoints of increasing eGFR as measured by cystatin...
...measured using the 4-variable Modification of Diet in Renal Disease (MDRD4) formula; eGFR measured by cystatin...
BioCentury | Jan 19, 2015
Clinical News

Masitinib: Phase III ongoing

...36, number of failures defined as 6-point drop in ALSFRS-R or death, overall survival (OS), cystatin...
BioCentury | Oct 22, 2014
Politics & Policy

FDA backs further study of kidney biomarkers

...seven urinary biomarkers for kidney injury. They include kidney injury molecule-1, albumin, total protein, beta-2-microglobulin, cystatin...
BioCentury | Jul 14, 2014
Clinical News

Pyridorin pyridoxamine: Phase III started

...ESRD); time to composite endpoint of >=100% serum creatinine increase or ESRD, change in serum cystatin-C...
BioCentury | Jun 2, 2014
Clinical News

Kiacta eprodisate: Completed Phase III enrollment

...increase in serum creatinine of >=80%, progression to ESRD, estimated glomerular filtration rate (eGFR), serum cystatin...
BioCentury | Dec 9, 2013
Clinical News

Kiacta eprodisate: Phase III ongoing

...creatinine of >=80%, progression to end-stage renal disease (ESRD), estimated glomerular filtration rate (eGFR), serum cystatin...
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